Immune ThrombocytopeniaPhase 2NCT05369377
Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia
A Phase 2 study testing Zanubrutinib and Eltrombopag in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 1 site in China.
Trial summary
Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Zanubrutinib and Eltrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
- Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count
- 2. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 3. Willing and able to sign written informed consent
Who cannot join
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
- congestive heart failure
- severe arrhythmia
- nursing or pregnant women
- aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
- creatinine or serum bilirubin levels each 1•5 times or more than the normal range
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- active or previous malignancy
- Unable to do blood routine test for the sake of time, distance, economic issues or other reasons
- History of clotting disorder
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial
Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP).
Read the detailed description
The investigators are undertaking a prospective trial of patients with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Eltrombopag is given with 50 mg once daily for up to 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. This study assessed the efficacy and safety of eltrombopag plus zanubrutinib.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Zanubrutinib, Eltrombopag
- Keywords
- BTK inhibitor, Thrombopoietin-receptor agonist
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called BTK inihibitor
Zanubrutinib 80mg po qd 6 weeks
EltrombopagDrug
eltrombopag 50 mg qd for up to 6 weeks. The eltrombopag dose could be increased from 50 mg to 75 mg after 3 weeks in patients whose platelet counts were less than 50 000 per μL. Treatment was discontinued in patients who attained a platelet count greater than 200 000 per μL.
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib and eltrombopag | Experimental | Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks. Receives: Drug: Zanubrutinib; Drug: Eltrombopag |
| Eltrombopag monotherapy | Active comparator | Eltrombopag is given as 50 mg qd for up to 6 weeks. Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
The proportion of patients who had an increase in platelet counts to 50 000 per μL or more after 6 weeks of treatment
Measured: 6 weeks
Secondary outcomes (8)
Overall response
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication after 6 weeks of treatment
Measured: 6 weeks
Complete response (CR)
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding
Measured: 6 weeks
Time to response
The time from starting treatment to time of achievement of Response
Measured: 6 weeks
Sustained response
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 12-month follow-up
Measured: 12 month
Number of patients with bleeding
Number of patients with bleeding complication ( WHO bleeding score)
Measured: 12 months
Number of patients with adverse events
Number of patients with adverse events
Measured: 12 months
Duration of response (DOR)
Duration of response at 12-month follow up
Measured: 12 months
Loss of response
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Navy General Hospital, Beijing, Beijing Aerospace General Hospital, Qilu Hospital of Shandong University, Beijing Tongren Hospital
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiaohui Zhang, md, Principal investigator, Peking University People's Hospital, Peking University Insititute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369377
- Sponsor's protocol ID
- Zan-Eltro-ITP
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05369377
- Acronym / sponsor ID
- Zan-Eltro-ITP
- Conditions
- Immune Thrombocytopenia
- Keywords
- BTK inhibitor, Thrombopoietin-receptor agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Navy General Hospital, Beijing, Beijing Aerospace General Hospital, Qilu Hospital of Shandong University, Beijing Tongren Hospital
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP).
Detailed description
The investigators are undertaking a prospective trial of patients with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Eltrombopag is given with 50 mg once daily for up to 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. This study assessed the efficacy and safety of eltrombopag plus zanubrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib and eltrombopag | Experimental | Drug: Zanubrutinib, Drug: EltrombopagZanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks. |
| Eltrombopag monotherapy | Active comparator | Drug: EltrombopagEltrombopag is given as 50 mg qd for up to 6 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
- Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count
- 2. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 3. Willing and able to sign written informed consent
Key exclusion criteria (9 listed)
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
- congestive heart failure
- severe arrhythmia
- nursing or pregnant women
- aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibAlso: BTK inihibitorZanubrutinib 80mg po qd 6 weeks | Drug | Zanubrutinib and eltrombopag |
| Eltrombopageltrombopag 50 mg qd for up to 6 weeks. The eltrombopag dose could be increased from 50 mg to 75 mg after 3 weeks in patients whose platelet counts were less than 50 000 per μL. Treatment was discontinued in patients who attained a platelet count greater than 200 000 per μL. | Drug | Eltrombopag monotherapy, Zanubrutinib and eltrombopag |
Primary outcome
Treatment response
Time frame: 6 weeks
The proportion of patients who had an increase in platelet counts to 50 000 per μL or more after 6 weeks of treatment
8 secondary outcomes
Overall response
Time frame: 6 weeks
Complete response (CR)
Time frame: 6 weeks
Time to response
Time frame: 6 weeks
Sustained response
Time frame: 12 month
Number of patients with bleeding
Time frame: 12 months
Number of patients with adverse events
Time frame: 12 months
Duration of response (DOR)
Time frame: 12 months
Loss of response
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohui Zhang, md principal investigator
Peking University People's Hospital, Peking University Insititute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib and Eltrombopag in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Zhang, MD (+8613522338836, zhangxh100@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.